The SEEA (SCI Energy Expenditure and Activity) Study (SEEA)

Investigating Factors Related to Nutritional Intake and Weight Gain Among Those With SCI Over the First 12 Months Following Discharge From Inpatient Rehabilitation

People with SCI are at higher risk of obesity and chronic diseases, such as hypertension, high cholesterol, diabetes and cardiovascular disease, than the general population. Researchers currently lack data on factors that influence weight gain among people with SCI. During this one-year observational study, study staff will enroll 60 individuals with SCI while they are inpatients at Baylor Scott & White Institute for Rehabilitation (BSWIR). Data will be collected at 3 time periods (before discharge and 6 and 12 months after discharge) in order to better understand factors that affect weight gain over the first 12 months following discharge from inpatient rehabilitation, such as nutritional intake, environmental access, psychosocial factors, energy requirements and risk factors for metabolic syndrome. These data will be used to inform future interventions for people with SCI.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases; Obesity; Metabolic Syndrome; Spinal Cord Injuries; Diet Habit

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Scott & White Institute for Rehabilitation - Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study participants are people who have incurred a spinal cord injury within the previous 18 months prior to study enrollment who have been admitted to inpatient rehabilitation at Baylor Scott & White Institute for Rehabilitation in Dallas, TX. Participants must have or be expected to regain enough arm/hand function to feed themselves independently and be willing and able to complete physical measurements and surveys.

Description

Inclusion Criteria:

• Adults ≥18 years with complete or incomplete spinal cord injury (SCI)
• Currently have or are expected to regain enough arm function within 6 months to feed themselves independently.
• Injury occurred within previous 18 months

Exclusion Criteria:

• Unwilling or unable to complete repeat assessments
• Cognitive impairment or brain injury that limits ability to provide data

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in nutritional intake	Measure self-report and hospital reported average daily caloric intake, macronutrients (protein, fats, carbohydrates), and micronutrient (sodium) over 3 days at each study time point: baseline, 6 months, and 1 year	1 year
Changes in environmental access to kitchen appliances and self-reported limitations and assistance needed for selecting, preparing, and eating meals.	Using the Assessment of life habits survey (abbreviated as LIFE-H) to determine the proportion of individuals with SCI who require assistance using kitchen appliances and preparing meals. Additional qualitative analyses will include examining the digital photos for intra-individual variation across time to determine whether there are changes to improve access to kitchen spaces and appliances.	1 year
Correlation between psychosocial factors (mood, stress, coping, and sleep) and caloric intake	Mood will be measured using the Positive and Negative Affect States Scale (PANAS); stress will be measured using the Perceived Stress Scale (PSS-4); coping will be measuring using the Daily Coping Inventory (DCI); sleep will be measured with the Pittsburgh Sleep Quality Index (PSQI). Caloric intake is measured through participant self-report through the HealthWatch 360 app, the Automated Self-Administered Recall System (ASA-24) or through hospital records.	1 year
Changes in resting metabolic rate	As measured by resting metabolic rate using a MedGem device	1 year
Time spent performing physical activity	Time spent performing physical activity at each of the study timepoints will be measured using an Actigraph device	1 year

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Investigators: Principal Investigator: Katherine Froehlich-Grobe, PhD, Baylor Scott & White Institute for Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2018
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Metabolic Syndrome; Spinal Cord Injuries
• Other Study ID Numbers: 016-277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No